ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study

Active, not recruiting

• Conditions: Adnexal Mass; Ovarian Cancer

• Registration Number: NCT04051502
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to find out how well ovarian sentinel lymph nodes (SLNs) can be identified with indocyanine green (ICG) dye during risk-reducing ovarian surgery.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-08-05
• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• Women undergoing surgery with the Gynecology Service at MSK.

• Women undergoing surgery for an adnexal mass without pre-operative suspicion of high stage disease, with or without a hysterectomy

  °For this protocol, "suspected high stage disease" will be defined as any patient with radiologic or clinical evidence of ovarian cancer which has spread outside of the ovary. Thus, only patients with an adnexal mass, or bilateral adnexal masses, are eligible.

• Women in whom MIS surgery is converted to a laparotomy will not be excluded as both surgical approaches, MIS and open, will be utilized.

• Women >/= 18 years of age

• Able to provide informed consent

• Albumin levels within normal range

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Exclusion Criteria

• Current non-GYN primary malignancy
• Prior or current history of uterine, cervical, peritoneal, or vulvovaginal malignancy
• Ongoing anticancer therapy
• Prior bilateral oophorectomy
• Known severe anaphylactic iodide allergy
• Known history of cirrhosis or other chronic liver disease, or women with hepatic dysfunction.
• Elevated transaminases (ALT, AST) and/or Alk Phos will be evaluated by the treating physician on a case by case basis.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number and location of ovarian sentinel lymph nodes visually identified after injection of ICG dye via one of three tested methods.	1 year	Evaluate for dye uptake in the regional lymphatic channels, and in the pelvic and para-aortic nodes using infrared imaging.

Trial Locations

Locations (7)

Memorial Sloan Kettering Bergen (Consent only ); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Basking Ridge (Consent only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Nassau (Consent only); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Commack (Consent only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester (Consent only); 🇺🇸 Harrison, New York, United States